What Is a Clinical Trial Protocol?

Epidemiol Psichiatr Soc. Apr-Jun 2010;19(2):116-7.

Abstract

Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

MeSH terms

  • Clinical Protocols*
  • Clinical Trials as Topic / standards*
  • Humans